Method of use of implantable percutaneous stimulation lead

ABSTRACT

A percutaneous neurological stimulation lead has at least a first lead body and a second lead body that interlock during implantation using interlocking elements. The first lead body has at least one first detail on the first lead body distal end that is configured to engage at least one second detail on the second lead body distal end that is complimentary to the first detail to mechanically couple the first lead body to the second lead body. Many embodiments of the implantable neurological stimulation lead with interlocking elements and its methods of operation are possible.

RELATED APPLICATION

This application is a continuation of U.S. application Ser. No.09/957217, filed Sep. 20, 2001. U.S. application Ser. No. 09/957217,filed Sep. 20, 2001, is incorporated herein by reference in itsentirety.

FIELD OF THE INVENTION

(This invention relates to a medical device and more particularly to aneurological stimulation lead that can be implanted in a human body.

BACKGROUND OF THE INVENTION

The medical device industry produces a wide variety of electronic andmechanical devices such as neurological stimulators, therapeuticsubstance infusion pumps, pacemakers, and defibrillators for treatingpatient medical conditions such as pain, movement disorders, functionaldisorders, spastisity, cancer, and cardiac disorders. Medical devicescan be configured to be surgically implanted or connected externally tothe patient receiving treatment and can be used either alone or incombination with pharmaceutical therapies and surgery to treat patientmedical conditions. For certain medical conditions, medical devicesprovide the best and sometimes the only therapy to restore an individualto a more healthful condition and a fuller life. One type of medicaldevice is an implantable neurological stimulation system typicallyincludes a neurostimulator, an electrical stimulation lead, and anextension such as shown in Medtronic, Inc. brochure “ImplantableNeurostimulation System” (1998). An implantable neurological stimulationsystem delivers electrical pulses to tissue such as neurological tissueor muscle to treat a medical condition.

Electrical stimulation leads can be configured as surgical leads thatrequire an incision for implantation and as percutaneous leads that areimplanted through a needle or introducer. Surgical leads are typicallyless constrained in their shape because the incision used forimplantation can be easily varied according to the surgical lead shape.Percutaneous leads are typically constrained in their shape because ofthe requirement to be inserted through a needle or introducer.Implantation of percutaneous leads is shown in Medtronic, Inc. brochureMedtronic Percutaneous Implant Guide. It is difficult to implant apercutaneous lead in close combination with another percutaneous leadbecause it is difficult to coordinate the mechanical relationshipbetween more than one percutaneous lead. It is also difficult toaccommodate multiple lead bodies within a needle or introducer.

BRIEF SUMMARY OF THE INVENTION

An implantable neurological stimulation lead with interlocking elementshas at least one first detail on the first lead body distal end that isconfigured to engage at least one second detail on the second lead bodydistal end that is complimentary to the first detail to mechanicallycouple the first lead body to the second lead body. The first lead bodyhas an outer body, a first distal end, and a first proximal end. Thefirst lead body has at least one electrode carried on the first distalend, at least one electrical connector carried on the first proximalend, at least one conductor electrically connecting the at least oneelectrode to the at least one connector carried in the lead body andelectrically insulated by the lead body, and at least one detail on thefirst distal end outer body. The second lead body has an outer body, asecond distal end, and a second proximal end. The second lead body hasat least one electrode carried on the second distal end, at least oneelectrical connector carried on the second proximal end, at least oneconductor electrically connecting the at least one electrode to the atleast one connector carried in the lead body, and at least one seconddetail on the second distal end outer body. Many embodiments of theimplantable neurological stimulation lead with interlocking elements andits methods of operation are possible.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a neurological stimulation system environment embodiment;

FIG. 2 shows a two lead embodiment;

FIG. 3 shows a three lead embodiment;

FIG. 4 shows a three lead and spacer embodiment;

FIG. 5 shows a two lead and spacer embodiment;

FIGS. 6 a-6 c show a coupling detail embodiments;

FIGS. 7 a-7 b show more coupling detail embodiments; and,

FIG. 8 shows a flow cart for a method.

FIGS. 9 a-c illustrates aspects of yet another an exemplary embodiment

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 shows an environment of an implantable neurological stimulationsystem 20. The implantable neurological stimulation system 20 comprisesan implantable neurological stimulator 22, a stimulation lead withinterlocking elements 23, a first lead body 24, and a second lead body26. The implantable neurological stimulator 22 provides a programmablestimulation signal that is delivered to a desired location or target tostimulate selected nerves or muscle tissue. The implantable neurologicalstimulator 22 is typically implanted in a subcutaneous pocket around theupper buttocks sometime after the stimulation lead has been implantedand its effectiveness verified.

FIGS. 2-5 show various implantable percutaneous stimulation lead withinterlocking elements 23 embodiments. An implantable neurologicalstimulation lead with interlocking elements 23 comprises a first leadbody 24 and a second lead body 26. These embodiments permit implantationof paddle or surgical style lead using percutaneous methods typicallywithout the use of a large needle or introducer. These embodiments alsoallow the mechanical adjustment of electrodes in more than onepercutaneous lead in relation to one another both axially and laterally.

The first lead body 24 has an outer body 28, a first distal end 30, anda first proximal end 32, at least one electrode 34, at least oneelectrical connector 36, at least one conductor 38, and at least onefirst detail 40 (FIGS. 6 a-7 b). The outer body 28 is manufactured froma material that is biocompatible and electrically insulating. Theelectrode 34 is carried on the first distal end 30. The electrode 34 canbe configured as a ring or any portion of a ring to include asubstantially flat electrode. The electrical connector 36 is carried onthe first proximal end 32. The conductor 38 electrically connects theelectrode 34 to the connector 36 and is insulated by the outer body 28.The first detail 40 is carried on the first distal end 30 outer body 28.The first lead body 24 is axially adjustable in relation to the secondlead body 26.

The second lead body 26 has a outer body 28, a second distal end 42, anda second proximal end 44, at least one electrode 34, at least oneelectrical connector 36, at least one conductor 38, and at least onesecond detail 46. The outer body 28 is manufactured from a material thatis biocompatible and electrically insulating. The electrode 34 iscarried on the second distal end 42. The electrode 34 can be configuredas a ring or any portion of a ring to include a substantially flatelectrode 34. The electrical connector 36 is carried on the secondproximal end 44. The conductor 38 electrically connects the electrode 34to the connector 36 and is insulated by the outer body 28. The seconddetail 46 is carried on the second distal end 42 outer body 28. Inaddition to the first lead body 24 and the second lead body 26, therecan be a third lead body, a forth lead body and so on.

The first detail 40 and the second detail 46 can be a wide variety ofcomplimentary geometries that can be axially engaged and adjustable tomechanically couple the first lead body first distal end 30 to thesecond lead body second distal end 42. The first detail 40 and seconddetail 46 can extend the entire length of the first lead body 24 andsecond lead body 26 or any portion thereof provided at least one portionincludes an area near the first lead body first distal end 30 and thesecond lead body second distal end 42. The first detail 40 on the firstdistal end 30 outer body 28 serves as a first means for connecting onthe first distal end 30 outer body 28. The first detail 40 iscomplimentary to the second detail 46 and configured to engage eachother to mechanically couple the first lead body first distal end 30 tothe second lead body second distal end 42. The first detail 40 alsoserves as a first means for connecting and the second detail 46 servesas a second means for connecting to mechanically couple the first leadbody first distal end 30 to the second lead body second distal end 42.Some embodiments can include an anchoring band 48 placed proximal to theelectrode 34 to secure the first lead body 24 to the second lead body26. Some embodiments can include at least one spacer body 50 having aspacer distal end 52 and a spacer proximal end 54. The spacer body 50has at least one first spacer detail that is complimentary to the firstdetail 40 and at least one second spacer detail that is complimentary tothe second detail 46. The spacer body 50 can be used to adjust lateralspacing between the electrodes 34 carried on the first 24 and secondlead bodies 26 through varying the width or the spacer body 50 or byusing multiple spacer bodies 50 in combination. Additionally, the spacerbody 50 can be used to assist in anchoring the first lead body 24 andsecond lead body 26.

FIGS. 6 a-7 b shows various details and complimentary detailsembodiment. The various details can be a wide variety of complimentarygeometries that can be axially engageable and adjustable to mechanicallycouple the first lead body distal end 30 to the second lead body distalend 42. For example, the first detail 40 can be a rail and the seconddetail 46 is a complimentary groove, and the first detail 40 can be aloop and the second detail 46 is the second lead body second distal end42 that is engaged by the loop.

FIG. 8 shows a method embodiment for implanting the neurologicalstimulation lead with interlocking elements 56. A method forinterconnecting two or more implantable percutaneous neurologicalstimulation leads comprises introducing a first lead body 58 having afirst detail through a needle or introducer. Positioning the first leadbody 60 at a first predetermined position. Removing the needle 62 whilemaintaining the first lead body at substantially the predeterminedposition. Engaging a second lead body 64 second detail into the firstlead body first detail. Guiding the second lead body 66 using the firstlead body as a guide. Positioning the second lead body 68 at a secondpredetermined position in relation to the first lead body. The methodcan also include adding one more spacers in a similar fashion to thefirst lead body and second lead body.

FIGS. 9 a and 9 b illustrate an implantable neurological stimulationlead 100 with interlocking elements. The lead 100 a first lead body 102,a second lead body 104, and a spacer body 106. The first lead body 102includes at least one first detail, such as a groove 108, on the distalend of the first lead body 102. The second lead body 104 includes atleast one second detail, such as a rail 110, on the distal end of thesecond lead body 104 that is complimentary to the first detail 108 onthe first lead body 102. FIG. 9 a and 9 b illustrate at least one firstspacer detail (e.g., rail 112) that is complimentary to the first detail108 and at least one second spacer detail (e.g., groove 114) that iscomplimentary to the second detail. FIGS. 9 b and 9 c illustrate thefirst detail 108 on the first lead body 102 as being configured toengage the at least one second detail 110 on the second lead body 104 tomechanically couple the distal end of the first lead body 102 to thedistal end of the second lead body 104.

Thus, embodiments of the implantable neurological stimulation lead withinterlocking elements are disclosed. One skilled in the art willappreciate that the present invention can be practiced with embodimentsother than those disclosed. The disclosed embodiments are presented forpurposes of illustration and not limitation, and the present inventionis limited only by the claims that follow.

1. A method of interconnecting two or more implantable percutaneousneurological stimulation leads, the method comprising: introducing afirst lead body having a first detail through a needle or introducer;positioning the first lead body at a first predetermined position;removing the needle or introducer while maintaining the first lead bodyat substantially the predetermined position; engaging a second lead bodysecond detail into the first lead body first detail; guiding the secondlead body using the first lead body as a guide; and positioning thesecond lead body at a second predetermined position in relation to thefirst lead body.
 2. A method of interconnecting two or more implantablepercutaneous neurological stimulation leads, the method comprising:introducing a first lead body through a needle or introducer, the firstlead body having a first interlocking feature; positioning the firstlead body at a first position; removing the needle or introducer whilemaintaining the first lead body at substantially the first position;engaging a second interlocking feature of a second lead body into thefirst interlocking feature of the first lead body, the first and secondinterlocking features being complementary to each other; guiding thesecond lead body using the first lead body as a guide; and positioningthe second lead body at a second position in relation to the first leadbody.
 3. The method of claim 2 wherein the first interlocking featurecomprises a groove and the second interlocking feature comprises a rail,the step of engaging a second interlocking feature of a second lead bodysecond into the first interlocking feature of the first lead bodyincluding: inserting the rail of the second lead body into the groove ofthe first lead body.